DEVICE: ROTEM® (04260160470068)
Device Identifier (DI) Information
ROTEM®
ap-tem®
In Commercial Distribution
503-04-US
Tem Innovations GmbH
ap-tem®
In Commercial Distribution
503-04-US
Tem Innovations GmbH
The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. ap-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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30595 | Multiple coagulation factor IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JPA | System, Multipurpose For In Vitro Coagulation Studies |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K101533 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5e73ccc7-bb97-4fd3-8549-5b003553dc10
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04260160470488
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined